Cardiovascular Update: Edwards Structural Heart, Repatha VESALIUS-CV, Baxdrostat Phase III, Regenerative Therapies and more
From Edwards’ structural heart focus, Repatha’s VESALIUS-CV results, to Baxdrostat’s Phase III breakthrough in resistant hypertension—this episode’s signals are powerful. We span cardiovascular devices, interventional cardiology, anticoagulation and lipid management, and regenerative therapies, with pivotal trial readouts and regulatory clearances across heart health, underscoring guideline-driven innovation and patient-centered impact.
In Today’s Newsletter
🫀 Edwards doubles down on structural heart following ESC/EACTS guideline shifts [1] [30 Sep 2025]
Key point: Edwards Lifesciences (Annette Brüls) highlights stronger guideline support for transcatheter aortic, mitral, tricuspid therapies and earlier intervention, aligning with its structural-heart focus.
Context: Discussion references EARLY TAVR with Sapien 3 and recent CE mark for asymptomatic AS indication, plus active M&A in TAVI/TMVR and PA sensor monitoring.
Implication: Signals pipeline investment and modality expansion.
💊 Taho files NDA for apixaban oral dissolving film (TAH3311) [2] [US • 01 Oct 2025]
Key point: Taho Pharmaceuticals submitted an FDA NDA for TAH3311, an apixaban ODF using its TDS platform, targeting patients with dysphagia.
Context: Company positions format to improve adherence and reduce aspiration risk; seeking global partners.
Implication: May expand screening, initiation, and follow-up at scale.
🩺 Elixir launches full market release of LithiX HC-IVL after CE mark [3] [EU/Asia • 01 Oct 2025]
https://cardiovascularnews.com/elixir-medicals-lithix-hc-ivl-system-gets-full-market-release/
Key point: LithiX HC-IVL enters full release; >400 patients treated across 16 countries since limited launch.
Context: Balloon-based system uses Hertz contact stress hemispheres for focal calcium modification; TCT 2025 data from 100-patient investigator-initiated study pending.
Implication: Introduces competition that may affect pricing and formulary access.
🧬 Repatha cuts events in primary prevention, VESALIUS-CV hits dual endpoints [4] [US • 02 Oct 2025]
Key point: Amgen reports evolocumab reduced MACE versus standard therapy in >12,000 high-risk adults without prior MI or stroke; dual primary endpoints met.
Context: Median follow-up ~4.5 years; no new safety signals; full data slated for AHA Nov 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
🛡️ FDA IDE cleared for FLOWer total-body embolic protection pivotal study [5] [US • 02 Oct 2025]
Key point: AorticLab received FDA IDE to begin US pivotal evaluation of FLOWer during TAVI and other intracardiac procedures.
Context: CE-marked in Q1 2024, used in complex EU cases; US sites include Montefiore.
Implication: Signals pipeline investment and modality expansion.
⚙️ CorWave shares first-in-human interim results for membrane LVAS [6] [02 Oct 2025]
https://cardiovascularnews.com/interim-results-of-fih-study-of-corwave-lvas-shared-at-hfsa-2025/
Key point: First patient met 30-day safety endpoint with no device-related AEs; transplant at day 84 without thrombus on explant.
Context: Membrane tech preserved physiologic pulsatility with consistent aortic valve opening; FIH plans minimum four patients before pivotal.
Implication: Signals pipeline investment and modality expansion.
🤖 SSi Mantra completes human-factors study, targets 510(k) in Q4 [7] [US • 02 Oct 2025]
https://cardiovascularnews.com/ssi-innovations-prepares-fda-submission-for-mantra-surgical-robot/
Key point: SS Innovations finished human-factors validation at Johns Hopkins and plans a multi-specialty 510(k) submission.
Context: Strategy pivoted from De Novo; 119 sites installed, >6,000 procedures including 60 telesurgeries and 310 cardiac cases.
Implication: Signals pipeline investment and modality expansion.
🧪 FDA clears Phase I start for UCLA’s ENPP1 antibody AD-NP1 [8] [US • 06 Oct 2025]
Key point: Investigational monoclonal antibody AD-NP1, targeting ENPP1 to enhance tissue repair, received FDA go-ahead for human trials.
Context: Academic program led by UCLA with public funding; preclinical efficacy and safety in mice and monkeys reported.
Implication: Signals pipeline investment and modality expansion.
🩸 Baxdrostat hits Phase III Bax24 primary endpoint in resistant HTN [9] [07 Oct 2025]
Key point: AstraZeneca reports statistically significant, clinically meaningful 24-hour ambulatory SBP reduction at 12 weeks versus placebo on top of SOC.
Context: Randomised rHTN trial, 2 mg QD; safety consistent with BaxHTN; late-breaker planned at AHA Nov 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Primary prevention lipid-lowering expands with positive PCSK9 outcomes.
- Structural heart adoption may accelerate with guideline shifts and protection tools.
- Coronary calcium modification tech diversifies beyond energy-based systems.
- Academic-led biologics programs are advancing into first-in-human without industry backing.
- Resistant hypertension gains a potential first-in-class aldosterone synthase inhibitor option.
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FAQ
What did Amgen’s VESALIUS-CV show for Repatha?
Amgen reported dual primary endpoints met with significant MACE reduction in high-risk adults without prior MI or stroke, with no new safety signals; full data are due at AHA Nov 2025 [4].
What is Taho’s TAH3311 and who is it for?
TAH3311 is an apixaban oral-dissolving film using TDS platform, aimed at patients with swallowing difficulty to improve adherence and reduce aspiration risk; NDA submitted to FDA [2].
How does Elixir’s LithiX HC-IVL differ from other calcium tools?
It is a balloon-based system using Hertz contact stress via metallic hemispheres for focal pressure amplification, seeking simpler workflow without extra capital equipment; full release follows CE mark [3].
What is the FLOWer device under FDA IDE?
A full-body embolic protection system intended for TAVI and other intracardiac procedures; US pivotal study to assess safety and effectiveness will initiate at sites including Montefiore [5].
What is AD-NP1 from UCLA targeting?
A monoclonal antibody against ENPP1, designed to modulate energy pathways and enhance tissue repair; FDA has cleared Phase I initiation [8].
What did AstraZeneca’s Bax24 trial conclude?
Baxdrostat 2 mg QD achieved significant 24-hour ambulatory SBP reduction at 12 weeks vs placebo in rHTN, with a safety profile consistent with prior studies; late-breaking AHA presentation planned [9].
Entities / Keywords
Edwards Lifesciences: Sapien 3, EARLY TAVR, Pascal, Evoque, JenaValve, Cordella.
Taho Pharmaceuticals: TAH3311, apixaban ODF, TDS platform.
Elixir Medical: LithiX HC-IVL, Hertz contact lithotripsy.
Amgen: Repatha, evolocumab, VESALIUS-CV, PCSK9 inhibitor.
AorticLab: FLOWer system, total-body embolic protection, TAVI.
CorWave: LVAS, membrane pump, pulsatility.
SS Innovations: SSi Mantra, surgical robotics, 510(k).
UCLA / AD-NP1: ENPP1 antibody, tissue repair.
AstraZeneca: Baxdrostat, Bax24, aldosterone synthase inhibitor, resistant hypertension.
References
https://cardiovascularnews.com/elixir-medicals-lithix-hc-ivl-system-gets-full-market-release/
https://cardiovascularnews.com/interim-results-of-fih-study-of-corwave-lvas-shared-at-hfsa-2025/
https://cardiovascularnews.com/ssi-innovations-prepares-fda-submission-for-mantra-surgical-robot/